Device |
hepatitis a test (antibody and igm antibody) |
Regulation Description |
Hepatitis A virus (HAV) serological assays. |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | LOL |
Premarket Review |
Division of Microbiology Devices
(DMD)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3310
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Guidance Documents
|
Third Party Review |
Not Third Party Eligible |